NCT07332416

Brief Summary

The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jan 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 2, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 8, 2026

Last Update Submit

April 1, 2026

Conditions

Gestational Diabetes

Keywords

Continuous glucose monitoringPostpartum glucose screeningDysglycemia

Outcome Measures

Primary Outcomes (1)

  • Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients

    Percentage of CGM-eligible patients that return a used CGM sensor

    20 weeks postpartum

Study Arms (3)

Postpartum CGM

ACTIVE COMPARATOR

Postpartum continuous glucose monitoring

Other: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott

Postpartum OGTT

NO INTERVENTION

Postpartum oral glucose tolerance test

No screening

NO INTERVENTION

No postpartum glucose screening

Interventions

Continuous glucose monitoring for 14 days using the Freestyle LibrePro by AbbottOTHER

Postpartum CGM

Postpartum CGM

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • weeks postpartum
  • Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
  • Oral Glucose Tolerance Test (OGTT) order placed in the medical record

You may not qualify if:

  • Pre-gestational diabetes
  • Non-English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Katherine A Sauder, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Sauder, MD

CONTACT

336-716-1280katherine.sauder@advocatehealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Aggregate data will be published from this pilot study; individual patient level data will be kept confidential.

Locations

US(1)